ACTRN12621001607864已完成2 期
A Placebo-controlled, Randomized, Double-blind Trial to Assess the Effects of Ergothioneine (ERG-001) on Cognition, Mood, and Sleep in Adult Men and Women at 4 and 16 weeks.
Blue California Ingredients0 个研究点目标入组 147 人开始时间: 2021年11月25日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 147
研究概览
简要总结
The study results are not yet available.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 55 Years 至 79 Years（—）
- 性别
- All
入选标准
- •1. Males and females
- •2. Aged >=55 & <=79 years of age at Informed Consent
- •3. Scores >=25 on the subjective memory complaints questionnaire (MAC-Q)
- •4. BMI >=18.5 and <=35 at time of clinic screening
- •5. Willing and able to provide Informed Consent
- •6. Able to access own email address
排除标准
- •1. Currently depressed (indicated by scores equal or greater to a score of 6 on GDS 15 questionnaire ).
- •2. Score of less or equal to 22 on the MoCA.
- •3. Self-reported Colour Blindness.
- •4. Aversion and/or intolerance/allergy to any of the following: Mushrooms, Microcrystalline cellulose, vegetarian capsules (hypromellose, purified water, titanium dioxide, carrageenan, pectin), magnesium stearate, or silicon dioxide.
- •5. Any condition or event, as confirmed by the trained Clinical Team Member, where cognitive impairment may occur, including but not limited to: head injury that required hospitalisation, brain surgery, transient ischemic attacks, stroke, coronary artery bypass surgery, other heart surgery, degenerative neurological disease, which in the opinion of the Investigator may affect the participant’s ability to participate in the study or the study results.
- •6. Previous diagnosis of Type 1 Diabetes.
- •7. HbA1c greater or equal to 6.5% for non-diabetics (equal to 48mmol/mol) or greater or equal to 7% (less or equal to 53mmol/mol) if diagnosed with Type 2 Diabetes and medically managed for at least 6 months, assessed at screening.
- •8. Untreated hypertension (Blood pressure equal to 155 mmHg and diastolic equal to 100 mmHg, obtained over three readings at the screening visit (unless applicant obtains a letter from medical professional indicating fit for inclusion)).
- •9. Current smoker (or history of smoking including within last 6 months).
- •10. History of Intellectual Disability or other developmental disorder (e.g., language disorder, ADHD, Autism).
- •11. Any mental health condition that is being actively treated either pharmacologically or by a licensed mental health professional .
- •12. Has undergone Chemotherapy or Radiotherapy treatment within preceding two years of screening.
- •13. Any of the following sleep disorders: Insomnia, Restless Legs Syndrome, Narcolepsy, Idiopathic Hypersomnia, Circadian Rhythm Disorders, Sleep Apnoea (unless actively treated by CPAP for at least the preceding 6-months).
- •14. Participation in a study utilising the same cognitive assessment measures within the previous 90 days of screening.
- •15. Self-reported regular use of sedatives (e.g., tranquillizers, Benzodiazepines,
- •antihistamines etc) to aid sleep defined as 3 or more nights per week over the four weeks preceding screening.
- •16. Self-reported alcohol intake exceeding 1 standard drink per day on average over the four weeks preceding screening in accordance with the Australian Government Guidelines.
- •17. Current or recent participation (within the last 60 days of screening) in any other clinical trial involving the administration of an active intervention for any purpose.
- •18. Consumption of more than one serve (approx. half a cup raw) of mushrooms per week on average over the 4 weeks preceding baseline assessment.
- •19. Consumption of greater than 400 mg/d intake of Caffeine per day averaged over the 4 weeks preceding screening.
- •20. Blood haematology and biochemistry test results outwith the normal reference range at screening, in the opinion of the treating doctor.
研究者
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